FDA Issues Order for Company to Stop Tobacco Product Sales

FDA has issued its first-ever order to stop the sale and distribution of tobacco products.

Feb 25, 2014

According to a press release from FDA, the agency has issued orders to stop the sale and distribution of four different tobacco products currently on the market. This marks the first time the agency has ever used authority under the Family Smoking Prevention and Tobacco Control Act to order a manufacturer to stop selling and distributing a product.

FDA has issued a manufacturer to halt production of the following products: Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone, and Sutra Bidis Menthol Cone. According to FDA, these products, “were found to be not substantially equivalent to tobacco products commercially marketed as of February 15, 2007, also known as predicate products. This means they can no longer be sold or distributed in interstate commerce or imported into the United States.”

Bidis are hand-rolled cigarettes filled with tobacco and wrapped in tendu tree leaves, then tied with string. Jash International manufactures them. The company did not meet the Tobacco Control Act’s requirements. According to the press release:

“Under the Tobacco Control Act, regulated products were allowed to stay on the market if companies submitted an application to the FDA by March 22, 2011. The law requires the FDA to review product applications so the agency can decide whether the products are substantially equivalent (SE) to valid predicate products. If a company fails to provide the necessary information to show that their product is SE to a predicate product, the FDA has the authority to declare a product not substantially equivalent, which means that it can no longer be sold or distributed in interstate commerce. In this case, Jash International did not identify eligible predicate tobacco products as required for the FDA to perform an SE review.”